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Medtronic under investigation for payments to doctors
Tuesday, 04 December 2007
Medtronic Inc. has revealed that it is under investigation by the U.S. Securities and Exchange Commission (SEC), the U.S. Attorney’s office and the Senate for possible violations concerning payments to doctors related to the company’s heart devices, including the recently recalled Sprint Fidelis lead wires. The information was made public in an October filing with the SEC.

According to the document, the SEC is investigating Medtronic for possible violations under the Foreign Corrupt Practices Act concerning “payments made directly or indirectly to government-employed doctors” in foreign countries, including Greece, Poland and Germany.

Meanwhile, the U.S. Attorney’s office in Pennsylvania is investigating the company for documents concerning one of Medtronic’s customers and “any payments of things of value provided to physicians.”

The Senate Finance Committee also sent two letters to Medtronic. The first asked for information about a possible financial link between the company and physicians. The second sought information about the Medtronic recall of the company’s Sprint Fidelis lead wires.

Medtronic issued the Sprint Fidelis recall in October after learning that the defibrillator lead wires were more than twice as likely to break after surgery as other lead wires made by the company. These broken wires could cause a defibrillator to fail to deliver a life-saving jolt in the event of a heart attack, or could cause the device to deliver painful, unnecessary shocks to the heart.

There have been at least 1,600 reports of malfunction or injury with the Sprint Fidelis leads, about one-third of which involved patients who had suffered painful shocks to the heart.